Philips Brilliance iCT CT Systems Recalled for Software Defects
Philips is recalling Brilliance iCT CT systems due to software issues affecting scan functions and safety features.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with software defects affecting safety features like exam stop and tube overheat, but no injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 559 Brilliance iCT SP (Model 728311) and Brilliance iCT (Model 728306) Computed Tomography X-ray systems. These devices were distributed worldwide, including nationwide in the United States.
The recall is due to numerous software issues in version 4.1.6. These issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error messages, length of acquisition, and image volume functions.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve these software issues.
The recalled product
- Product
- Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 559
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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